Leap Therapeutics, Inc. Announces the First Patient Dosed with TRX518 Combination Therapy in Advanced Solid Tumors Trial
January 16, 2018 at 07:00 am
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Leap Therapeutics, Inc. announced that the first patient has been dosed in a Phase 1 clinical trial evaluating Leap’s GITR agonist, TRX518, in combination with gemcitabine chemotherapy or in combination with KEYTRUDA® (pembrolizumab) or Opdivo® (nivolumab), anti-PD-1 therapies marketed by Merck (known as MSD outside the United States and Canada) or Bristol-Myers Squibb, respectively. TRX518 has demonstrated the ability to reduce immunosuppressive regulatory T cells and to activate tumor-killing T effector cells in clinical and preclinical studies. The combination of TRX518 with anti-PD-1 immunotherapy has strong scientific rationale and could act synergistically, enabling improved responses without significant additional toxicity. The combination arms evaluating TRX518 with gemcitabine includes both dose escalation and dose confirmation cohorts and are designed to evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of the combination. The TRX518 + gemcitabine study will enroll approximately 32 patients. The combination arms evaluating TRX518 with pembrolizumab or nivolumab includes both dose escalation and dose confirmation cohorts and are designed to evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of the combinations.
Leap Therapeutics, Inc. is a biopharmaceutical company. The Company is focused on developing targeted and immuno-oncology therapeutics. Its advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-related protein 1 (DKK1) protein. DKK1 is also a modulator of CKAP4/PI3K/AKT signaling. DKN-01 is being developed in patients with esophagogastric, gynecologic, and colorectal cancers. Its second clinical-stage program is FL-301, a humanized monoclonal antibody targeting Claudin18.2, being developed in patients with gastric and pancreatic cancer. It also has two preclinical antibody programs, FL-302 and FL-501. FL-302 is a Claudin18.2/CD137 (also known as 4-1BB) bispecific antibody that is in preclinical development. FL-501 is a monoclonal antibody in preclinical development that targets growth and differentiation factor 15 (GDF15), which is a cytokine that is produced at elevated levels in response to various stresses.